FDA Quality System Regulation for Medical Devices (21 CFR Part 820): A Practitioner's Guide to Management Controls (sections 820.20 Management ... 820.22 Quality Audit, and 820.25 Personnel) - Softcover

Daugherty, Mr D G

Softcover

ISBN 10: 1522840249 ISBN 13: 9781522840244

Publisher: CreateSpace Independent Publishing Platform, 2015

Synopsis

The Practitioner’s Guide to Management Controls was written to provide a simple, single source of information for United States Food and Drug Administration’s (FDA) requirements for Management Controls as described in 21 CFR Part 820 Quality System Regulation (QS Regulation) for Medical Devices. Management Controls include sections 820.20 Management Responsibility, 820.22 Quality Audit, and 820.25 Personnel of this medical device regulation. The Practitioner’s Guide to Management Controls is written for the practitioner to use as a tool to help develop management controls prospectively for a new quality system or to perform gap assessments between existing management controls in a quality system against the FDA requirements and expectations provided in this book.

About this title

About the Author

Donald G. Daugherty is an accomplished medical device quality assurance professional with over 25 years of experience in quality engineering, management, and compliance with some of the world’s largest medical device manufacturing companies. He is highly knowledgeable in requirements of FDA QSR 820, ISO 13485, and ISO 14971, manufacturing process validation (IQ, OQ, PQ), quality system development, Corrective and Preventive Action (CAPA), and quality performance metrics and analytics. He is exceptionally skilled in statistical techniques, process improvement, problem solving, and root cause analysis. Donald G. Daugherty is also a senior member of the American Society for Quality (ASQ) and maintains professional certifications through ASQ as a Certified Six Sigma Black Belt, Quality Engineer, and Quality Auditor.

Edition details

• Publisher: CreateSpace Independent Publishing Platform
• Publication date: 2015
• Language: English
• ISBN 10: 1522840249
• ISBN 13: 9781522840244
• Binding: Paperback
• Number of pages: 58